Confirmation of Systemic Autoimmune Diseases in the Agricultural Health Study
Primary Purpose
Autoimmune Disease
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Autoimmune Disease focused on measuring Rheumatoid Arthritis, Lupus, Scleroderma, Sjogren's Syndrome, Farming, Autoimmune Disease, Exposure
Eligibility Criteria
INCLUSION CRITERIA: Agricultural workers and their spouses. EXCLUSION CRITERIA: Children will not be included. There are no exclusions based on ethnicity or race. Participants who are unable to complete a telephone interview because of chronic illness (including cognitive impairment) or language or hearing difficulties will not be eligible.
Sites / Locations
- University of Iowa
- Battelle Centers for Public Health Research and Evaluation
- NIEHS, Research Triangle Park
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00341198
First Posted
June 19, 2006
Last Updated
June 30, 2017
Sponsor
National Institute of Environmental Health Sciences (NIEHS)
1. Study Identification
Unique Protocol Identification Number
NCT00341198
Brief Title
Confirmation of Systemic Autoimmune Diseases in the Agricultural Health Study
Official Title
Confirmation of Systemic Autoimmune Diseases in the Agricultural Health Study
Study Type
Observational
2. Study Status
Record Verification Date
December 12, 2006
Overall Recruitment Status
Completed
Study Start Date
April 2, 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 12, 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Environmental Health Sciences (NIEHS)
4. Oversight
5. Study Description
Brief Summary
Autoimmune diseases may involve nearly any organ and are characterized by abnormal activation or response of certain cells. Evidence suggests that farm work, exposure to silica from farming activities and exposure to pesticides may contribute to the development of autoimmune disease. Associations between autoimmune diseases and farming, however, have not been extensively investigated, and exposure data in the currently available studies are extremely limited.
One of the major challenges in conducting population-based research on autoimmune diseases is case ascertainment. Self-report of previous diagnosis has proven to be unreliable. This protocol outlines a strategy to confirm self-reported diagnoses of systemic autoimmune diseases (rheumatoid arthritis, systemic lupus erythematosus, scleroderma, and Sjogren syndrome) within the Agricultural Health Study group (AHS; a group of licensed pesticide applicators and spouses who completed a questionnaire). The confirmed cases will constitute a refined case group to allow analyses of pesticides and other farming-related exposures as possible risk factors for these diseases using data that have already been collected.
Subjects will be selected from participants in the AHS who reported one of the diseases being studied. A short telephone interview will be conducted with participants, who will be requested to provide written consent for review of information from medical records. To confirm the self-diagnosis, participants' physicians will be contacted. Specific information will be requested in the form of a checklist. Responses will be reviewed for evidence of diagnosis and classified as confirmed, probable, physician-diagnosed, or unconfirmed.
Secondary objectives of this study are to:
assess the correct interpretation of conflicting self-reports that are provided at two different times.
evaluate the usefulness of specific questions that could potentially be used in future studies to validate self-reported cases of rheumatoid arthritis in men.
Detailed Description
Farming-related exposures (including pesticides and silica) may contribute to the etiology of autoimmune diseases. However, associations between autoimmune diseases and farming have not been extensively investigated, and exposure data in the currently available studies is extremely limited. One of the major challenges in conducting population-based research on autoimmune diseases is case ascertainment. Self-report of previous diagnosis has been shown to be very unreliable. This protocol outlines a strategy to confirm self-reported diagnoses of systemic autoimmune diseases (rheumatoid arthritis, systemic lupus erythematosus, scleroderma, and Sjogren syndrome) within the Agricultural Health Study (AHS) cohort. The confirmed cases will constitute a refined case group to allow etiologic analyses of pesticides and other farming-related exposures as possible risk factors for these diseases using data that have already been collected. The codes can also be used in a nested case-control study that could be designed to collect additional exposure data (for example, on silica-related exposures).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autoimmune Disease
Keywords
Rheumatoid Arthritis, Lupus, Scleroderma, Sjogren's Syndrome, Farming, Autoimmune Disease, Exposure
7. Study Design
Enrollment
700 (false)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA:
Agricultural workers and their spouses.
EXCLUSION CRITERIA:
Children will not be included.
There are no exclusions based on ethnicity or race.
Participants who are unable to complete a telephone interview because of chronic illness (including cognitive impairment) or language or hearing difficulties will not be eligible.
Facility Information:
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Battelle Centers for Public Health Research and Evaluation
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27713
Country
United States
Facility Name
NIEHS, Research Triangle Park
City
Research Triangle Park
State/Province
North Carolina
ZIP/Postal Code
27709
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
11095463
Citation
Jubault V, Penfornis A, Schillo F, Hoen B, Izembart M, Timsit J, Kazatchkine MD, Gilquin J, Viard JP. Sequential occurrence of thyroid autoantibodies and Graves' disease after immune restoration in severely immunocompromised human immunodeficiency virus-1-infected patients. J Clin Endocrinol Metab. 2000 Nov;85(11):4254-7. doi: 10.1210/jcem.85.11.6988.
Results Reference
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Confirmation of Systemic Autoimmune Diseases in the Agricultural Health Study
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